FIASP 100 units/mL pump cartridge injectable solution

Introduction

Package Leaflet: Information for the User

Fiasp 100units/ml PumpCart solution for injection in cartridge

insulin aspart

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Fiasp and what is it used for
2. What you need to know before you use Fiasp
3. How to use Fiasp
4. Possible side effects
5. Storage of Fiasp
6. Contents of the pack and other information

1. What is Fiasp and what is it used for

Fiasp is an insulin that is administered at mealtimes with a rapid effect of lowering blood sugar. Fiasp is a solution for injection of insulin aspart and is used to treat diabetes mellitus in adults, adolescents and children from 1 year of age. Diabetes is a disease in which the body does not produce enough insulin to control blood sugar levels. Treatment with Fiasp helps to prevent complications of diabetes.

About PumpCart

The PumpCart cartridge is used in a pump designed to be used with this cartridge:

• Covers your total daily insulin needs: the one needed throughout the day (basal) and the one needed at mealtimes (bolus).
• Before using a PumpCart cartridge in the pump, you must have received detailed instructions from your doctor or nurse.

Daily basal insulin need:

When using Fiasp in a pump, the insulin is released constantly into your body.

• This covers your basal insulin need during the day.

• Before setting or changing the basal dose, read the pump manual (user manual) carefully.
• If you stop the pump, note that the effect of the insulin will gradually decrease over 3 to 5 hours.

Mealtime insulin need (bolus):

• Must be injected from 2 minutes before starting to eat, with the possibility of administering up to 20 minutes after the start of the meal (see section 3, How to use Fiasp).
• The maximum effect occurs between 1 and 3 hours after administration at mealtimes.
• The effect lasts from 3 to 5 hours.

2. What you need to know before you use Fiasp

Do not use Fiasp

• if you are allergic to insulin aspart or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you start using Fiasp. It is important that you know the following:

• Low blood sugar (hypoglycaemia): if your blood sugar level is too low, follow the instructions for low blood sugar that appear in section 4 "Possible side effects". Compared to other insulins that are administered at mealtimes, Fiasp starts to lower blood sugar faster. If you suffer from hypoglycaemia, you may feel it sooner after an injection of Fiasp.
• High blood sugar (hyperglycaemia): if your blood sugar level is too high, follow the instructions for high blood sugar that appear in section 4 "Possible side effects".
• Change from other insulins. Your doctor may need to advise you on your insulin dose.
• If you are combining your insulin treatment with pioglitazone (an oral anti-diabetic medicine used to treat type 2 diabetes), talk to your doctor as soon as possible if you experience symptoms of heart failure such as unusual difficulty breathing or rapid weight gain or localised swelling caused by fluid retention (oedema).
• Eye disorders: a sudden improvement in blood sugar control can cause a temporary worsening of visual disorders related to diabetes such as diabetic retinopathy.
• Nerve damage pain: if your blood sugar level improves very quickly, you may suffer from nerve-related pain that is usually transient.
• Joint swelling: when starting to use the medicine, the body may retain more fluid than it should, causing inflammation of the ankles and other joints. This effect usually disappears quickly.
• Make sure you use the correct type of insulin, always check the label of the insulin before each injection to avoid accidental mixing of insulins.
• Treatment with insulins can cause the body to produce antibodies to insulin (a substance that acts against insulin). However, only in very rare cases will this require a change in your insulin dose.

In case of reduced vision, see section 3 "How to use Fiasp".

Certain conditions and activities can affect your insulin requirements. Talk to your doctor:

• if you have kidney, liver, adrenal, pituitary or thyroid problems.
• if you do more physical exercise than usual or if you want to change your usual diet, as this may affect your blood sugar level.
• if you are ill, continue your treatment with insulin and talk to your doctor.
• if you are going to travel abroad, travelling to different time zones may affect your insulin needs and injection times.

When using Fiasp, it is strongly recommended that you record the name and batch number of each pack to keep a record of the batches used.

Fiasp PumpCart can only be used with the following insulin pump system: Accu-Chek Insight and YpsoPump insulin pumps. Do not use with other pumps, as it may deliver an incorrect dose and cause high or low blood sugar.

Changes in the skin at the injection site

The injection site should be rotated to help avoid changes in the fatty tissue, such as thickening of the skin, shrinking of the skin or lumps under the skin. Insulin may not work very well if injected into a thickened, shrunk or swollen area (see section 3 "How to use Fiasp"). Inform your doctor if you notice any changes in the injection site. Inform your doctor if you are currently injecting into these affected areas, before starting to inject into a different area. Your doctor may indicate that you should check your blood sugar levels more closely and adjust the insulin or the dose of your other anti-diabetic medications.

Children and adolescents

This medicine is not recommended for use in children under 1 year of age.

Other medicines and Fiasp

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Some medicines affect your blood sugar level and this may mean that you need to adjust your insulin dose.

The following are the main medicines that may affect your treatment with insulin.

Your blood sugar level may decrease (hypoglycaemia) if you take:

• other medicines for diabetes (oral and injectable)
• antibiotics of the sulphonamide type (used to treat infections)
• anabolic steroids (such as testosterone)
• beta-blockers (used to treat high blood pressure or angina pectoris)
• salicylates (used to relieve pain and lower fever)
• monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• angiotensin-converting enzyme inhibitors (ACE inhibitors) (for treating certain heart problems or high blood pressure)

Your blood sugar level may increase (hyperglycaemia) if you take:

• danazol (a medicine that acts on ovulation)
• oral contraceptives (birth control pill)
• thyroid hormones (to treat thyroid problems)
• growth hormone (to treat a deficiency of this hormone)
• glucocorticoids (such as "cortisone", to treat inflammation)
• sympathomimetics (such as adrenaline, salbutamol or terbutaline, to treat asthma)
• thiazides (to treat high blood pressure or if the body retains too much fluid (fluid retention))

Octreotide and lanreotide, used to treat acromegaly, a rare disorder characterised by excessive production of growth hormone. These medicines may increase or decrease your blood sugar level.

If you are in any of the above situations (or are unsure), talk to your doctor or pharmacist.

Using Fiasp with alcohol

If you drink alcohol, it may change your insulin needs, as your blood sugar level may be increased or decreased. Therefore, you should check your blood sugar level more often than usual.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. This medicine can be used during pregnancy, however, it may be necessary to adjust the insulin dose while you are pregnant and after giving birth. The amount of insulin you need usually decreases during the first 3 months of pregnancy and increases during the remaining 6 months. During pregnancy, careful control of your diabetes is necessary. Avoiding low blood sugar (hypoglycaemia) is especially important for the health of your baby. After having your baby, your insulin requirements will probably return to what they were before pregnancy.

There are no restrictions on the use of Fiasp during the breastfeeding period.

Driving and using machines

Low blood sugar can affect your ability to drive or use tools or machines. If you have low blood sugar, your ability to concentrate and react may be impaired. This could put your life or the lives of others at risk. Ask your doctor if you can drive if:

• you have frequent episodes of hypoglycaemia
• you find it difficult to recognise the symptoms of hypoglycaemia

Important information about some of the ingredients of Fiasp

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

3. How to use Fiasp

If you are blind or have reduced vision and cannot read the pump screen, do not use this pump without help. Ask for help from a person without visual problems and who is trained in the use of the pump.

Dose and when to use Fiasp

Always use your insulin and adjust the doses of the whole day (basal) and mealtimes (bolus) as your doctor has explained to you. In case of doubt, consult your doctor, nurse or pharmacist

• Adjust your mealtime insulin (bolus) based on blood sugar measurement and food intake.

Adults

Fiasp doses at mealtimes should be administered just before (0 to 2 minutes) starting to eat, with the possibility of administering up to 20 minutes after the start of the meal.

Children

Fiasp doses at mealtimes should be administered just before (0 to 2 minutes) starting to eat, with the possibility of administering up to 20 minutes after the start of the meal in situations where it is uncertain when the child will eat. Consult your doctor about these situations.

If you want to change your usual diet, consult your doctor, pharmacist or nurse beforehand, as a change in diet may alter your insulin needs.

When using other medicines, ask your doctor if it is necessary to adjust your treatment.

Use in elderly patients (65 years or older)

This medicine can be used in elderly patients. Talk to your doctor about possible changes in your dose.

If you have kidney or liver problems

If you have kidney or liver problems, you may need to check your blood sugar level more often. Talk to your doctor about possible changes in your dose.

Injecting Fiasp

This medicine is only intended for injection under the skin (subcutaneous injection). Only for use with pumps designed to be used with this cartridge.

• Before using the PumpCart cartridge in the pump, you must have received detailed instructions from your doctor or nurse.
  • Talk to your doctor if you need to inject the insulin by another method.

Where to inject

• Normally, the injection site for insulin is in the front of the waist (abdomen). However, if your doctor recommends it, you can inject it into the upper arm.
• Do not inject into a vein or muscle.
• When changing the infusion set (catheter and cannula), make sure to change the injection site of the needle. This can reduce the risk of developing changes under the skin (see section 4 "Possible side effects").

Do not use Fiasp

• if the cartridge or the device containing the cartridge you are using falls, is damaged or is crushed. Return it to your supplier.
• if the cartridge has not been stored correctly (see section 5 "Storage of Fiasp").
• if the insulin does not have a clear and colourless appearance.

On the other side of this leaflet, detailed instructions are provided on how to use PumpCart.

How to inject Fiasp

• Read and follow the instructions in the pump manual (user manual) that come with your insulin pump.
• Make sure you use a suitable infusion set (catheter and needle) for your insulin pump.
• Check the name and concentration on the cartridge label (PumpCart) to ensure it is Fiasp.
• The infusion set (catheter and needle) and the PumpCart cartridge must not be shared.
• The infusion set (catheter and needle) must be changed according to the instructions that appear in the product information that comes with the infusion set.

What to do in case of pump failure

You should always have an alternative insulin delivery system on hand to inject insulin under the skin (e.g. an injection pen or syringes) in case the pump fails.

If you use more Fiasp than you should

If you use too much insulin, your blood sugar level may become very low (hypoglycaemia), see section 4 "Low blood sugar".

If you forget to use Fiasp

If you forget to inject the insulin, your blood sugar level may become very high (hyperglycaemia). See section 4 "High blood sugar".

Three simple steps that can help you avoid low or high blood sugar levels:

• Always carry spare Fiasp cartridges.
• Always carry something that indicates you are diabetic.
• Always carry sugary products with you. See section 4 "What to do if your blood sugar level is low".

If you stop treatment with Fiasp

Do not stop your treatment with insulin without consulting your doctor. Stopping the administration of insulin could cause a very high blood sugar level (severe hyperglycaemia) and ketoacidosis (a problem consisting of an excessive amount of acid in the blood that is potentially fatal). See symptoms and recommendations in section 4 "High blood sugar".

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Low blood sugar level (hypoglycemia)is a very frequent adverse effect of insulin treatment (it can affect more than 1 in 10 people). It can be very serious. A severe drop in blood sugar can lead to loss of consciousness. Severe hypoglycemia can cause brain damage and put your life at risk. If you have symptoms of low blood sugar, take measures to increase your blood sugar level immediately. See the recommendations "Low blood sugar level" below.

If you experience a severe allergic reaction(including anaphylactic shock) to insulin or any of the components of Fiasp (the frequency at which this occurs is unknown), discontinue treatment with this medicine and contact the emergency medical service immediately.

The symptoms of a severe allergic reaction may include:

• local reactions (such as rash, redness, and itching) spreading to other parts of the body
• sudden feeling of nausea with sweating
• starting to vomit
• experiencing difficulty breathing
• having palpitations or feeling dizzy.

Allergic reactionssuch as generalized skin rash and facial swelling may occur. These are uncommon and may affect up to 1 in 100 people. Consult a doctor if the symptoms worsen or if you see no improvement within a few weeks.

Skin changes at the injection site:If insulin is injected in the same place, the fatty tissue can shrink (lipoatrophy) or become thicker (lipohypertrophy) (these are uncommon and may affect up to 1 in 100 people). Lumps under the skin can also occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; the frequency at which this occurs is unknown). Insulin may not work very well if injected into a lumpy, shrunken, or thickened area. Change the injection site to help avoid these skin changes.

Other adverse effects include:

Frequent(may affect up to 1 in 10 people)

Reaction at the injection site: Localized reactions may appear at the injection site. Symptoms may include: rash, redness, inflammation, bruising, irritation, pain, and itching. These reactions usually disappear after a few days.

Skin reactions: Signs of skin allergy such as eczema, rash, itching, hives, and dermatitis may appear.

General effects of insulin treatment including Fiasp

• Low blood sugar level (hypoglycemia) (very frequent)

Low blood sugar levels may occur if:

You drink alcohol, inject too much insulin, exercise more than usual, eat very little, or skip a meal.

Warning symptoms of low blood sugar, which can appear suddenly:Headache, difficulty speaking, palpitations, cold sweat, cold and pale skin, nausea, excessive hunger, tremors, nervousness or anxiety, unusual fatigue, weakness, and drowsiness, confusion, difficulty concentrating, temporary changes in vision.

What to do if your blood sugar level is low

• If you are conscious, treat your low blood sugar immediately with 15-20 g of fast-acting carbohydrates: take glucose tablets or a sugary product, such as fruit juice, sweets, or cookies (always carry glucose tablets or sugary products with you in case you need them) and adjust the administration of insulin or stop your pump.
• It is recommended that you recheck your blood glucose levels after 15-20 minutes and retreat if your blood glucose levels are still below 4 mmol/l.
• Wait until the symptoms of hypoglycemia have disappeared or your blood sugar level has stabilized. Continue with insulin treatment as usual.

What people close to you should do if you lose consciousness

Inform the people you spend time with that you have diabetes. Tell them what the consequences of low blood sugar might be, including the risk of losing consciousness.

Tell them that if you become unconscious, they should do the following:

• lay you on your side to prevent choking
• seek immediate medical attention
• do not give you anything to eat or drink, as you might choke.

You may regain consciousness more quickly if someone who knows how to do so administers a glucagon injection to you.

• If you are given glucagon, you should take glucose or a sugary product as soon as you regain consciousness.
• If you do not respond to glucagon treatment, you should be treated in a hospital.

If severe hypoglycemia is not treated, it can cause brain damage over time. This can be temporary or permanent. It can even lead to death.

Talk to your doctor if:

• you have had low blood sugar levels that have caused you to lose consciousness
• you have been given a glucagon injection
• you have had several episodes of low blood sugar recently.

You may need to adjust the dose or frequency of your insulin injections, diet, or exercise.

• High blood sugar level (hyperglycemia)

High blood sugar levels may occur if:

You eat more or exercise less than usual, drink alcohol, have an infection or fever, do not inject enough insulin, repeatedly inject less insulin than you need, forget to inject insulin, or interrupt insulin treatment.

Warning symptoms of high blood sugar, which usually appear gradually:Redness of the skin, dry skin, feeling of drowsiness or fatigue, dry mouth, fruity breath odor (acetone), increased need to urinate, thirst, loss of appetite, nausea or vomiting.

These can be symptoms of a very serious condition called ketoacidosis. It is an accumulation of acid in the blood because the body is metabolizing fat instead of sugar. If left untreated, it can lead to diabetic coma and even death.

What to do if your blood sugar level is high

• Check your blood sugar level.
• Administer a correction dose of insulin if you have been taught how to do so.
• Check the ketone level in your urine.
• If you have ketones, seek medical attention immediately.

Reporting adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Fiasp

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the label and carton after EXP. The expiration date is the last day of the month indicated.

Before first use

Store in a refrigerator (between 2°C and 8°C). Do not freeze. Keep away from the freezer. Store the cartridge in the outer packaging to protect it from light.

Once opened or if carried as a spare

• Do not refrigerate during use.
• You can store your cartridge (PumpCart) at room temperature (below 30°C) for a maximum of 2 weeks.
• After that, you can use it for up to 7 days below 37°C in a pump designed for use with this cartridge.
• Store the PumpCart cartridge in the outer packaging until use to protect it from any damage. Always protect the cartridge from light during use.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Fiasp

• The active substance is insulin aspart. 1 ml of solution contains 100 units of insulin aspart. Each cartridge contains 160 units of insulin aspart in 1.6 ml of solution.
• The other ingredients are phenol, metacresol, glycerol, zinc acetate, disodium phosphate dihydrate, arginine hydrochloride, nicotinamide (vitamin B3), hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) (see the end of section 2 "Important information about some of the ingredients of Fiasp") and water for injectable preparations.

Appearance of Fiasp and package contents

Fiasp is presented as a clear, colorless, and aqueous injectable solution in a cartridge.

Package sizes of 5 or a multipack of 25 (5 packs of 5) cartridges of 1.6 ml. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Novo Nordisk A/S,

Novo Allé,

DK-2880 Bagsværd, Denmark

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

Instructions for using Fiasp PumpCart pre-filled cartridge.

Fiasp PumpCart can only be used with an insulin pump system designed to be used with this cartridge,such as the Accu-Chek Insight and YpsoPump insulin pumps.

• It must not be used with other devices not designed for the PumpCart cartridge.
• As this may cause an incorrect dose of insulin to be administered, resulting in high blood sugar (hyperglycemia) or low blood sugar (hypoglycemia).

Read these instructions carefullybefore using your PumpCart cartridge.

Also, read the pump manual (user manual)that comes with your insulin pump.

• The PumpCart cartridge is ready for use directly in the pump.

• The PumpCart cartridge contains 1.6 ml of insulin aspart solution, equivalent to 160 units.

• This medicine must never be mixed with any other medicine.

• Do not refill the PumpCart cartridge. Once empty, it must be discarded.

• Always ensure that you have a spare PumpCart cartridge available.

• Do not use the PumpCart cartridge in an insulin pen, as this may cause incorrect dosing.

• The PumpCart cartridge must be protected from excessive heat and light during storage and use.

• The PumpCart cartridge must be kept out of the reach of other people, especially children.

1. Before inserting a PumpCart cartridge into your pump

• Bring the PumpCart cartridge to room temperature.

• Remove the PumpCart cartridge from its carton and blister pack.

• Check the label to ensure it is a Fiasp PumpCart cartridge.

• Check the expiration date on the label and carton.

• Always check that the PumpCart cartridge looks as it should (Figure A). Do not use it if it is damaged, leaking insulin, or if the plunger has moved, making the bottom of the plunger visible above the white band. This may mean that insulin has leaked out. In Figure A, the bottom of the plunger is hidden behind the white band as it should be. If you suspect that the PumpCart cartridge is damaged, return it to your supplier.

• Check that the insulin in the PumpCart cartridge is clear and colorless. If the insulin appears cloudy, do not use the PumpCart cartridge. The cartridge may contain a small amount of air in the form of small bubbles.

1. Inserting a new PumpCart cartridge of Fiasp into your pump

• Follow the instructions in the user manual that comes with your pump to insert a new PumpCart cartridge into your pump.

• Insert the PumpCart cartridge into the cartridge compartment of the pump. The plunger side is inserted first.

• Connect the infusion set to the PumpCart cartridge by connecting the adapter to your pump.

• Follow the instructions in the pump user manual to continue using your pump.

1. Removing the empty PumpCart cartridge of Fiasp from your pump

• Follow the instructions in the pump user manual to remove the empty PumpCart cartridge from your pump.

• Remove the adapter from the infusion set from the empty PumpCart cartridge.

• Discard the empty PumpCart cartridge and the used infusion set as instructed by your doctor or nurse.

• Follow the steps described in sections 1 and 2 to prepare and insert a new PumpCart cartridge into your pump.